Spinal Cord Stimulation to Treat Post-operative Atrial Fibrillation

Not Applicable

Terminated

• Conditions: Atrial Fibrillation
• Interventions: Device: Holter Recording_ NEMon DR220 Holter Recorders; Device: Spinal Cord Stimulation System

• Registration Number: NCT02530203
• Lead Sponsor: Medtronic BRC

Brief Summary

Patients will be randomized to control and spinal cord stimulation arm (SCS) to investigate the effect of SCS on the occurrence of post-operative atrial fibrillation in the five days after surgery.

Detailed Description

Pre market single center clinical research feasibility study. Non blinded randomized controlled study. 52 patients undergoing CABG procedure will be enrolled and randomized into two different group (26 person each): the Spinal Cord Stimulation (SCS) and the control group. The first group will be implanted before the CABG procedure with a temporary SCS lead (5 days) while the second one will not. The lead will be connected to an external stimulator.

The day of the CABG surgery, before the scheduled procedure, the patients in the treatment group will be implanted with the SCS lead. CABG procedure follows the SCS lead implantation. SCS will be switched off before surgery.

After the CABG procedure, all patients will be hospitalized for minimally five days at the end of which they will be discharged. The Primary Endpoint data will be collected from the day of CABG procedure (Day-0) until Day-5. SCS lead will be removed on Day-5.

1-week follow up visit will be performed one week after discharge. End-points will be evaluated at various time before, during and after surgery. In both groups arrhythmic episodes for primary and secondary endpoints will be recorded via a Holter monitor (recording 5 days continuously).

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-05-11
• Study First Submitted QC: 2015-08-19
• Study First Posted: 2015-08-20
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-05
• Last Update Posted: 2016-04-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

1. Patients which will be subjected to an OFF-pump CABG procedure
2. More than 18 years of age
3. Subject is able and willing to give informed consent.

Exclusion Criteria

1. Patients with known history of atrial arrhythmias.

2. Patients who are not treated with β-blockers unless heart rate is too low for β-blockers assumption.

3. Participation in another clinical trial which may affect the outcome within 3 months prior to day of procedure.

4. Other surgical interventions (e.g. valve replacement) programmed in the same surgical session

5. Resting pulse rate ≤45 beats / min as assessed before daily doses of β-blockage is administered.

6. Hypotension (RR systolic <100 or RR diastolic <50).

7. Conduction abnormalities on the ECG consisting of a 1st degree atrioventricular block or a complete bundle branch block.

8. Subject is diagnosed with epilepsy or history of seizures.

9. Coagulation abnormalities as determined by anticoagulation guidelines for neuroaxial procedures 2011.

10. Patients not stabilized on an anti-arrhythmic drug regimen for the last 30 days.

11. Patients with long QT syndrome.

12. Patients with Brugada syndrome.

13. Patients affected by Polyneuropathy (e.g. due to diabetes).

14. Patients affected by pericarditis

15. Patients who underwent procedures in the past, which are expected to have changed the innervation of the heart for example:

    • Ablation procedure
    • Cardiac surgery

16. Pregnant patients or nursing (subjects who are of child bearing potential and are not on a reliable form of birth control will undergo a pregnancy test)

17. Patients already implanted with cardiac devices

18. Patients with existing implanted neurostimulators

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional treatment	Holter Recording_ NEMon DR220 Holter Recorders	Non interventional group, patients that belong to this arm will receive the conventional treatment for CABG and they will wear the Holter for 5 days.
Spinal Cord Stimulation System	Holter Recording_ NEMon DR220 Holter Recorders	This group will receive the Spinal Cord Stimulation System and they will wear the Holter for 5 days.
Spinal Cord Stimulation System	Spinal Cord Stimulation System	This group will receive the Spinal Cord Stimulation System and they will wear the Holter for 5 days.

Primary Outcome Measures

Name	Time	Method
Atrial fibrillation	5 days after CABG	AT/AF will be defined as an episode with an atrial rate \>175 bpm lasting ≥ 20 seconds.

Secondary Outcome Measures

Name	Time	Method
Cardioversion	5 days after CABG	Description of number of cardioversion needed in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
BP	5 days after CABG	Description of 1) intra arterial blood pressure as averaged over the first 24 hours after surgery and 2) arterial blood pressure as determined using a blood pressure cuff at a specific time on Day-2, Day-3, Day-4 and Day-5 after surgery in the treatment (SCS) and control group.
Description of burden of AT/AF episodes in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.	5 days after CABG	AT/AF burden
VT/VF episodes	5 days after CABG	Description of the total number of VT/VF episodes in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
Bladder function	5 days after CABG	The extra time the bladder catheter will be kept in the patients after the first 2 days after surgery will be described in the treatment (SCS) and control group in order to assess bladder function.
Burden VT/VF episodes	5 days after CABG	Description of the burden of VT/VF episodes in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
HRV	5 days after CABG	Improvement LF/HF ratio of Heart Rate Variability (HRV) by SCS. SCS On and Off will be compared in each patients in the treatment (SCS) group before surgery and 5 days after surgery.
Medication	5 days after CABG	Description of integral medication related to AT/AF occurrence and pain in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
Hospitalizations Days	1 week after discharge	Description of hospitalizations longer than 5 days as required by the protocol and clinical practice in the treatment (SCS) and control group.
Pain on the VAS scale	5 days after CABG	Description of pain-score due to CABG surgery measured with a VAS score three times a from Day-1 till Day-5 after surgery in the treatment (SCS) and control group.
Description of the total number of AT/AF episodes in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.	5 days after CABG	AT/AF episodes
Premature atrial beats	5 days after CABG	Description of the amount of premature atrial beats in the treatment (SCS) and control group from the end of the procedure till Day-5 after surgery.
HR	5 days after CABG	Description of 1) heart rate as averaged over the first 24 hours after surgery and 2) heart rate as determined using a blood pressure cuff at a specific time on Day-2, Day-3, Day-4 and Day-5 after surgery in the treatment (SCS) and control group.

Trial Locations

Locations (1)

Medisch Spectrum Twente (MST); 🇳🇱 Enschede, Netherlands